Metabolic effects of mustard

ISRCTN	ISRCTN19147515
DOI	https://doi.org/10.1186/ISRCTN19147515
Protocol serial number	Mustard1
Sponsor	Institute of Metabolic Science
Funders	National Institute for Health Research, BRC Seed Fund, FP7 People: Marie-Curie Actions, Wellcome Trust, Medical Research Council, British Heart Foundation, Biotechnology and Biological Sciences Research Council

Submission date: 03/07/2017
Registration date: 20/07/2017
Last edited: 07/08/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Increasing energy use (energy expenditure) is a way for overweight or obese people to lose weight. Mustard’s pungent component AITC has the potential to increase energy expenditure and may have other beneficial effects on metabolism. The aim of this study is to investigate the effects of mustard on energy expenditure, glucose and fat utilization, body temperature, cold and hunger scores and blood values such as glucose.

Who can participate?
Healthy volunteers aged 18 to 65

What does the study involve?
Participants are studied on three different days. On each day they take either a spoon of mustard or capsulated mustard, or capsules with a placebo (dummy) mixture. At 30-minute intervals indirect calorimetry (a way to measure energy expenditure and fat and glucose utilization), cold/hunger scores and blood tests are performed. Temperature is measured continuously using a temperature monitoring pill. In between the measurements participants are allowed to read or watch TV but confined to bed. Blood samples are taken via an venous catheter (tube into a vein). Afterwards they eat a test meal during which appetite and food intake are measured.

What are the possible benefits and risks of participating?
There were no specific risks or benefits for the volunteers from participating in the study. Volunteers are reimbursed for travelling expenses and offered compensation for time spent participating.

Where is the study run from?
University of Cambridge Metabolic Research Laboratories, Wellcome Trust-MRC, Institute of Metabolic Science, Addenbrooke’s Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2012 to January 2014

Who is funding the study?
The trial was funded by grants from the NIHR, BRC Seed Fund, Marie Curie Fellowships, Welcome Trust Fellowship, MRC, BHF and the BBSRC

Who is the main contact?
Dr M Langeveld

Contact information

Dr Mirjam Langeveld
Scientific

Academisch Medisch Centrum, F5-169
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised cross over trial
Secondary study design	Randomised cross over trial
Study type	Participant information sheet
Scientific title	Metabolic effects of mustard allyl-isothiocyanate compared to placebo: a randomised cross over trial
Study objectives	Ingestion of mustard (containing the active ingrediënt allyl-isothiocyanate (AITC) ) induces thermogenesis (primary outcome) and alters body temperature, cold and hunger sensations, plasma metabolic parameters and energy intake (secondary outcomes).
Ethics approval(s)	Cambridge Central East of England Research Ethics Committee, 22/03/2012, ref: 6/Q0108/84
Health condition(s) or problem(s) studied	Overweight, obesity
Intervention	In this study with a crossover design, 10 healthy subjects were studied under temperature controlled conditions after an overnight fast. After the ingestion of capsulated mustard (10 grams) or unpackaged mustard (10 grams) or capsulated placebo mixture, measurements of energy expenditure, substrate oxidation, core temperature, cold and hunger scores and plasma parameters were repeated every 30 minutes during 150 minutes. Randomisation was done by flipping a coin by the investigator to decide between the administration of capsulated mustard or the administration of capsulated placebo mixture. Unpackaged mustard was given as final intervention since participants could not be blinded to this intervention. After the experiments were performed, energy intake was measured in a test meal using the universal eating monitor.
Intervention type	Supplement
Primary outcome measure(s)	Energy expenditure (thermogenesis), measured using by indirect calorimetry using a ventilated canopy respiratory gas exchange (GEM; GEMNutrition, Daresbury, UK) at baseline and 30, 60, 90, 120 and 150 minutes after the intervention
Key secondary outcome measure(s)	Measured at baseline and 30, 60, 90, 120 and 150 minutes after the intervention: 1. Core body temperature, measured using a temperature pill (VitalSense, Respironics, Bend, OR, USA) 2. Cold and hunger sensations, determined by asking the participant to rate the sensation of cold of the whole body and hands separately on a 1 to 10 scale, with ratings as following; 1 was rated as not at all cold and 10 was the coldest one had ever felt. Similarly for the degree of hunger, with ratings as: 1 for not hungry at all, and 10 was rated as the most hungry one had ever felt 3. Plasma metabolic parameters; blood samples taken via an indwelling venous catheter 3.1. Glucose measured using the Hexokinase method on a Siemens Dimension RXL AutoAnalyser, reagents and calibrators purchased from Siemens 3.2. Non-esterified free fatty acids (NEFAs) measured using the Roche Free Fatty Acid kit 3.3. Free thyroxin (fT4) measured by time-resolved fluorescence immunoassay on an AutoDELFIA analyser (Perkin Elmer) using kits from Perkin Elmer 3.4. Cortisol measured by fluorescence immunoassay on the Siemens Centaur Autoanalyser 4. Energy intake determined by using the Universal Eating Monitors (UEM)(The Sussex Meal Patterning System) during the test meal at 160 minutes after the intervention. Subjects ate a homogenous test meal (e.g. pasta) containing normal energy percent ratios (~30% carbohydrates, ~30% protein and ~40% fat). Test meal intake continuously monitored using the UEM equipment
Completion date	03/01/2014

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	All
Target sample size at registration	10
Key inclusion criteria	1. Healthy volunteers 2. Men and women 3. Non-smokers 4. Age between 17 and 65 years 5. No known medical conditions 6. Not taking any medications or supplements likely to influence energy expenditure
Key exclusion criteria	1. Known medical conditions 2. Using medication or supplements likely to influence energy expenditure or other metabolic parameters
Date of first enrolment	01/04/2012
Date of final enrolment	19/11/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Cambridge Metabolic Research Laboratories, Wellcome Trust-MRC, Institute of Metabolic Science, Addenbrookes Hospital

Hills Road
Cambridge
CB2 0QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available as this was not outlined in the original study set up and application to the medical ethics committee. The original data will be held at the University of Cambridge Metabolic Research Laboratories, Wellcome Trust-MRC, Institute of Metabolic Science, Addenbrookes Hospital.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/08/2018: Publication reference added.
24/07/2017: Ethics approval information added.